Standard Operating Procedure for Hygroscopicity Testing in Granules

1) Purpose

The purpose of this SOP is to outline the procedure for conducting hygroscopicity testing of granules in the pharmaceutical industry to evaluate the moisture absorption properties under controlled conditions.

2) Scope

This SOP applies to all personnel involved in hygroscopicity testing of granules within the pharmaceutical manufacturing department.

3) Responsibilities

Quality Control (QC) Analyst: Responsible for performing hygroscopicity testing.
Production Supervisor: Responsible for overseeing the testing process and ensuring compliance.

4) Procedure

1. Sample Preparation:
   1. Weigh accurately a specified amount of granule sample into a suitable container.
   2. Label the containers with batch details and sample identification.
2. Conditioning:
   1. Place the containers with granule samples in a controlled humidity chamber set at specified conditions (e.g., 25°C and 60% relative humidity).
   2. Allow the samples to equilibrate for a defined period (e.g., 48 hours).
3. Weighing:
   1. Remove the containers from the humidity chamber and immediately weigh each sample.
   2. Record the initial weight (W₀) of each sample.
4. Re-conditioning:
   1. Return the containers to the humidity chamber for additional exposure (if required by protocol).
   2. Repeat the weighing process at specified intervals until a consistent weight change is observed.
5. Calculations:
   1. Calculate the percentage weight gain or loss using the formula:
      % Change = [(W_t – W₀) / W₀] × 100
   2. Report the results including the average and range of weight change observed.
6. Documentation:
   1. Record all testing parameters, observations, and results in the designated logbook or electronic system.
   2. Prepare a final report summarizing the hygroscopicity testing outcomes.

5) Abbreviations, if any

SOP: Standard Operating Procedure
QC: Quality Control

6) Documents, if any

Hygroscopicity Testing Protocol, Humidity Chamber Calibration Records, Testing Logbook

7) Reference, if any

Pharmacopeial guidelines on moisture content testing of pharmaceutical granules.

8) SOP Version

Version 1.0